The FDA issued a Safety Informational on May 15, 2019 warning consumers, tattoo artists, and retailers about using or selling certain tattoo inks contaminated with microorganisms.

For details on all tattoo ink recalls, please meet our Recalls & Alerts Page. As with any cosmetic product, if you feel an agin event that yous recollect may be related to the use of tattoo inks, you should written report the result to the FDA.

Consumers, manufacturers, tattoo artists, and health care providers may accept questions on tattoos, permanent makeup, temporary tattoos, and henna (mehndi). Here is condom and regulatory information on these products.

Safety and Regulatory Background

FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics. When we identify a safety problem associated with a cosmetic, including a tattoo ink, we investigate and accept action, as appropriate, to foreclose consumer disease or injury. The pigments used in the inks are color additives, which are subject to premarket approval nether the Federal Food, Drug, and Cosmetic Human action. Even so, because of other competing public wellness priorities and a previous lack of show of safety issues specifically associated with these pigments, FDA traditionally has not exercised regulatory dominance for color additives on the pigments used in tattoo inks. The actual practice of tattooing is regulated by local jurisdictions.

During 2003 and 2004, FDA became aware of more than 150 reports of agin reactions in consumers to certain permanent makeup ink shades, and it is possible that the actual number of women afflicted was greater. The inks associated with this outbreak were voluntarily recalled by the company that marketed them in 2004. In the jump of 2012, we received reports of infections from contaminated inks, resulting in their recall and market withdrawal. In the fall of 2017, a firm voluntarily recalled several colors and sizes of tattoo inks, due to microbial contamination identified past an FDA survey. In addition, concerns raised by the scientific community regarding the pigments used in tattoo inks take prompted FDA to investigate their condom use. FDA continues to evaluate the extent and severity of adverse events associated with tattooing and is conducting research on tattoo inks. Every bit new information is assessed, we will consider whether additional deportment are necessary to protect public health.

In addition to the reported adverse reactions, areas of concern include tattoo removal, infections that result from tattooing, and the increasing diversity of pigments and diluents being used in tattooing. More than 50 different pigments and shades are in use, and the list continues to grow. Although a number of colour additives are approved for use in cosmetics, none is canonical for injection into the skin. Using an unapproved colour condiment in a tattoo ink makes the ink adulterated. Many pigments used in tattoo inks are non canonical for skin contact at all. Some are industrial grade colors that are suitable for printers' ink or automobile paint.

Nevertheless, many individuals choose to undergo tattooing in its various forms. For some, it is an aesthetic choice or an initiation rite. Some choose permanent makeup every bit a time saver or because they have concrete difficulty applying regular, temporary makeup. For others, tattooing is an adjunct to reconstructive surgery, particularly of the confront or breast, to simulate natural pigmentation. People who have lost their eyebrows due to alopecia (a form of hair loss) may choose to have "eyebrows" tattooed on, while people with vitiligo (a lack of pigmentation in areas of the skin) may endeavor tattooing to aid camouflage the condition.

Whatsoever their reason, consumers should be aware of the risks involved in order to make an informed decision.

Risks Involved in Tattooing

The following are the primary complications that can result from tattooing:

  • Infection. Unsterile tattooing equipment and needles tin transmit infectious diseases, such every bit HIV, hepatitis, and skin infections caused past Staphylococcus aureus ("staph") and other bacteria*. Tattoos received at facilities non regulated by your country or at facilities that use unsterile equipment (or re-apply ink) may prevent y'all from beingness accepted as a claret or plasma donor for twelve months. Infections likewise take resulted from contaminated tattoo inks, even when the tattoo artist has followed hygienic procedures. These infections tin require prolonged treatment with antibiotics.
  • Removal problems. Despite advances in laser technology, removing a tattoo is a painstaking process, unremarkably involving several treatments and considerable expense. Complete removal without scarring may exist impossible.
  • Allergic reactions. Although FDA has received reports of numerous adverse reactions associated with sure shades of ink in permanent makeup, marketed past a detail manufacturer, reports of allergic reactions to tattoo pigments accept been rare. All the same, when they happen they may be particularly troublesome because the pigments can be hard to remove. Occasionally, people may develop an allergic reaction to tattoos they have had for years.
  • Granulomas. These are nodules that may grade around material that the body perceives every bit foreign, such equally particles of tattoo pigment.
  • Keloid formation. If you are prone to developing keloids -- scars that grow beyond normal boundaries -- you are at risk of keloid formation from a tattoo. Keloids may class any time yous injure or traumatize your skin. Micropigmentation: Land of the Art, a volume written by Charles Zwerling, M.D., Annette Walker, R.Northward., and Norman Goldstein, M.D., states that keloids occur more than oft equally a consequence of tattoo removal.
  • MRI complications. There have been reports of people with tattoos or permanent makeup who experienced swelling or burning in the affected areas when they underwent magnetic resonance imaging (MRI). This seems to occur only rarely and plainly without lasting effects.There have also been reports of tattoo pigments interfering with the quality of the MRI image. This seems to occur mainly when a person with permanent eyeliner undergoes MRI of the eyes. However, the risks of avoiding an MRI when your doctor has recommended one are likely to be much greater than the risks of complications from an interaction betwixt the MRI and tattoo or permanent makeup. Instead of avoiding an MRI, individuals who take tattoos or permanent makeup should inform the radiologist or radiologic technologist.

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A Common Problem: Dissatisfaction

A mutual problem that may develop with tattoos is the desire to remove them. Removing tattoos and permanent makeup can be very difficult.

Although tattoos may be satisfactory at first, they sometimes fade. Likewise, if the tattooist injects the pigments too deeply into the skin, the pigments may migrate beyond the original sites, resulting in a blurred advent.

Some other crusade of dissatisfaction is that the human torso changes over time, and styles change with the flavor. The permanent makeup that may take looked flattering when first injected may later clash with changing pare tones and facial or torso contours. People who programme to have facial corrective surgery are advised that the advent of their permanent makeup may become distorted. The tattoo that seem stylish at the time may become dated and embarrassing later on. And changing tattoos or permanent makeup is not as like shooting fish in a barrel equally changing your listen.

Consult your healthcare provider most the best removal techniques for you.

Temporary Tattoos, Henna /Mehndi, and "Black Henna"

Temporary tattoos, such equally those applied to the skin with a moistened wad of cotton, fade several days after awarding. FDA has issued an import alarm for certain foreign-fabricated temporary tattoos containing colors that are not permitted for this use or don't comport the FDA-mandated list of ingredients. Additionally, FDA has received reports of allergic reactions to temporary tattoos.

In a similar activity, FDA has issued an import alert for henna intended for use on the skin. Henna is canonical simply for use equally a hair dye, non for direct application to the skin. Also, henna typically produces a reddish brown tint, raising questions about what ingredients are added to produce the varieties of colors labeled as "henna," such as "black henna" and "blue henna." Hair dyes are non approved for use on the skin, and some people may be sensitive to them. FDA has also received reports of allergic reactions to temporary tattoos that incorporate henna and those consisting only of hair dye. Some reactions take resulted in scarring.

To learn more, see Temporary Tattoos, Henna/Mehndi, and "Black Henna."

Reporting Adverse Reactions

FDA urges consumers and healthcare providers to report adverse reactions from tattoos, permanent makeup, and temporary tattoos, too every bit problems with tattoo removal.

Consumers and healthcare providers can report problems to MedWatch, FDA'southward problem-reporting program, on the Web or at 1-800-332-1088 ; or by contacting the nearest FDA consumer complaint coordinator.

For more information, run across the additional resources listed under Tattoos and Permanent Makeup.

* For related information on infections from tattooing, see the following documents from the Centers for Disease Control: Viral Hepatitis B Fact Sheet and "Methicillin-Resistant Staphylococcus aureus Peel Infections Among Tattoo Recipients --- Ohio, Kentucky, and Vermont, 2004-2005" (published in Morbidity and Mortality Weekly Study, June 23, 2006).

Related Resource

  • Tattoo Inks Pose Wellness Risks--Consumer Update
  • Tattoo Ink-Related Infections--Awareness, Diagnosis, Reporting, and Prevention
  • Think Before Y'all Ink: Are Tattoos Safe?--Consumer Update
  • Tattoos and Permanent Makeup: Market and Chemical science--Webinar
  • Temporary Tattoos & Henna/Mehndi
  • Import Alert #53-19: Detention Without Physical Examination of Henna Based Skin Color